• NOV-ERA is designed to assess the efficacy and safety of ontunisertib in approximately 320 patients with symptomatic Fibrostenosing Crohn’s disease (FSCD)
• Global, randomized, placebo-controlled, dose-ranging study to evaluate three dose levels of ontunisertib, with endoscopic passability at Week 24 as primary endpoint
• Study initiation represents an important milestone in the development of ontunisertib as a potential first targeted anti-fibrotic treatment for FSCD

Antwerp, Belgium, October 13, 2026 – Agomab Therapeutics NV (‘Agomab’), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that the first patient has been dosed in NOV-ERA, the Company’s global Phase 2b study evaluating ontunisertib in patients with symptomatic FSCD.
NOV-ERA is a randomized, double-blind, placebo-controlled, multicenter Phase 2b study designed to assess the safety and efficacy of ontunisertib. The study is expected to enroll approximately 320 adult patients globally. Participants will be randomized to receive either ontunisertib at one of three dose levels (400 mg BID, 200 mg BID, and 100 mg BID), or a matching placebo for a treatment duration of
52 weeks.
The initiation of NOV-ERA follows the positive Phase 2a STENOVA results that support continued clinical development of ontunisertib in FSCD. The recently announced positive long-term safety and tolerability findings of the open-label extension (OLE) part of the STENOVA Phase 2a study provide strong support for the inclusion of a 400 mg BID treatment arm in the NOV-ERA study.

Open-Label Extension (OLE) Data of STENOVA Phase 2a study with ontunisertib in Fibrostenosing Crohn’s disease (FSCD) selected for oral presentation at UEG Week 2026
Results support initiation of global NOV-ERA Phase 2b study in FSCD
Agomab-sponsored symposium to discuss the importance of targeting fibro-inflammation in inflammatory bowel disease (IBD)

Antwerp, Belgium, October 8, 2026 – Agomab Therapeutics NV (‘Agomab’) a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that OLE data of the Phase 2a STENOVA study will be presented in an oral session at United European Gastroenterology (UEG) Week 2026, taking place October 17-20 in Barcelona, Spain. The OLE study (Part B of STENOVA) evaluated long-term treatment with ontunisertib 200 mg BID for up to 60 weeks in symptomatic FSCD patients. The study assessed the long-term safety and PK profile of ontunisertib and explored the event rate and disease progression in FSCD patients.

• Favorable safety and tolerability profile maintained through up to 60 weeks of treatment with ontunisertib in Fibrostenosing Crohn’s disease (FSCD) patients
• Low annualized FSCD-related event rate of 3%, with one endoscopic balloon dilation (EBD) and no surgeries reported over the full treatment period
• Radiological assessment shows trend for fibrotic stricture stabilization over treatment course
• Sustained disease control observed across symptoms and disease activity scores in Open-Label Extension Study (OLE)
• Results support initiation of global NOV-ERA Phase 2b study in FSCD in the coming months
• Company to host webcast today at 8:30 a.m. Eastern Time

Antwerp, Belgium, October 1, 2026 – Agomab Therapeutics NV (‘Agomab’) a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD, a severe manifestation of Crohn’s disease characterized by progressive bowel fibrosis and intestinal strictures.
The OLE study (Part B) evaluated long-term treatment with ontunisertib 200 mg BID on top of standard of care. Of the participants eligible to roll over into the OLE study from the 12-week placebo-controlled Part A of STENOVA, 94% elected to enter the study (n=49).
The results demonstrated a generally favorable long-term safety and tolerability profile of ontunisertib 200 mg BID for up to 60 weeks of treatment, as well as maintenance of the gut-restricted pharmacokinetic (PK) profile observed in Part A of the trial. Sustained disease control, with low symptoms and disease activity scores and radiological stricture stabilization, was also observed. Importantly, a low FSCD-related annualized event rate of 3% was reported in patients treated with ontunisertib 200 mg BID up to 60 weeks.